Patients Undergoing Percutaneous Coronary Intervention (PCI) Through Optimal Platelet Inhibition

NCT01582217 | Completed DMC

• 2 other identifiers: GCO 12-0028FWA # 00005656 and 00005651
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the the 1-year rates of ischemic and bleeding complications in patients whose dual antiplatelet therapy regimen post-PCI has been determined with the use of a clinical algorithm that includes both clinical risks and platelet reactivity while on chronic clopidogrel therapy.

Conditions

Percutaneous Coronary Intervention; Dual Antiplatelet Therapy; Aspirin; Clopidogrel

Keywords

Bleeding; Risk Score; Outcomes; Prasugrel

Outcome Measures

Primary Outcomes (1)

• MACE

  Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)

  12 months

Secondary Outcomes (1)

• Rates of major bleeding

  12 months

Study Arms (3)

SA + 5mg prasugrel

Prasugrel 5 mg group: Patients with Intermediate or high bleeding risks and PRU ≥ 230 are Prescribed 5mg of prasugrel daily along with aspirin.

ASA + 10 mg prasugrel

Prasugrel 10 mg group: Patients with Low bleeding risk and high ischemia risk and PRU ≥ 230 are prescribed 10 mg of prasugrel daily along with aspirin.

ASA + 75 mg clopidogrel daily

Clopidogrel 75 mg group (control): PRU ≤ 230; high bleeding risk or high ischemic risk; patients with active malignancy, age \>75; Wt\< 60kg with previous CVA or TA are prescribed 75 mg of clopidogrel daily along with aspirin.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects in any of the participating sites who are on chronic clopidogrel treatment and return for PCI will be considered for this study.

You may qualify if:

• The subject has provided informed written.
• The subject must be ≥ 18 years of age (or minimum age as required by local regulations) at the time of enrollment.
• Patient is established on chronic clopidogrel therapy when he/she returns for PCI, and the components of DAPT are determined by the clinical decision algorithm as local standard of care.
• The subject is willing and able to cooperate with the study procedures and required follow-ups.

You may not qualify if:

• Patients with cardiogenic shock will be excluded.
• The subject is participating in an investigational device or drug study. Subject must have completed the follow up phase of any previous study at least 30 days prior to enrolment in this study.
• Pregnant women.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Daiichi Sankyo: collaborator
• Accumetrics, Inc.: collaborator

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• George Dangas, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 20, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 23, 2015

Record last verified: 2015-12

Locations

US (1)